BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 5

    MDR report key: 2829662 · Received November 13, 2012

    Report

    Report Number
    1818910-2012-27657
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 7, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE 960015, WORK ORDER (B)(4) WAS MANUFACTURED ON 07TH SPETEMBER 2006. 10 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE 158140000, WORK ORDER (B)(4) WAS MANUFACTURED ON 11TH OCTOBER 2006. 12 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT CODE 158114108, WORK ORDER (B)(4) WAS MANUFACTURED ON 19TH APRIL 2006. 24 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. PRODUCT REVIEW NO PRODUCT WAS RETURNED FOR DIMENSIONAL AND VISUAL REVIEW THEREFORE NO REVIEW WAS CONDUCTED. NO OTHER PRODUCT FROM THIS LOT WAS AVAILABLE TO PULL AND ASSESS. PERIPHERY SYSTEMS REVIEWED AND FOUND TO MEET SPECIFICATIONS. HISTORICAL REVIEW A REVIEW OF CUSTOMER COMPLAINTS FOR ALL PRODUCTS WAS CONDUCTED. NO TREND WAS FOUND FOR ANY OF THE ABOVE LOT CODES, PRODUCT CODES, OR PRODUCT FAMILY FOR THIS FAILURE MODE. DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, INABILITY TO CONFIRM FAILURE MODE DUE TO NO PRODUCT RETURNED AND NO OTHER PRODUCT AVAILABLE FROM LOT TO REVIEW AND NO SIMILAR COMPLAINTS WITHIN AN 18-MONTH PERIOD, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    (B)(4). DURING EVALUATION SITE CONCLUDED THAT PATIENT NEEDS TO BE REVISED TO ALLEVIATE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC*SIGMA C/R NPOR FEM RT SZ 5 DEPUY FEMORAL KNEE IMPLANT JWH DEPUY IRELAND 2229336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention